Refrigeration-shelf-stable ultra-pasteurized or pasteurized infant formula

ABSTRACT

Refrigeration-shelf-stable ready-to-feed and concentrated infant formulas can be prepared through a ultra-pasteurization and/or pasteurization process. The ultra-pasteurized and/or pasteurized infant formulas contain complete balanced quantities of nutrients.

RELATED APPLICATIONS

The present application is a continuation-in-part to U.S. Ser. No.09/305,071, filed May 4, 1999, now U.S. Pat. No. 6,039,985, issued Mar.21 2000, which is a continuation-in-part of U.S. Ser. No. 08/975,692,filed Nov. 21, 1997, now U.S. Pat. No. 5,985,339 issued Nov. 16,1999,which claimed priority to U.S. Provisional Application Ser. No.60/031,637, filed Nov. 22, 1996, all of which are incorporated in theirentirety herein by reference.

FIELD OF THE INVENTION

This invention relates to refrigeration-shelf-stable ready-to-feed andconcentrated infant formulas and products which are prepared usingultra-pasteurization or pasteurization processes.

BACKGROUND OF THE INVENTION

Infant formula is used as a supplement to or substitute for breast milkwhen a mother cannot or does not want to breast feed her infant.Ideally, the composition of the infant formula would be exactly the sameas the composition of human milk. Nonetheless, because infant formulasare typically made with cow milk (and sometimes soy protein), on amolecular level, these formulas are not the same as human milk.Nonetheless, infant formulas are designed to mimic the formulation ofhuman milk as much as possible. Furthermore, infant formulas shouldcontain nutrients as listed by governmental standards, for instance bythe U.S. Code of Federal Regulations (21 CFR 107.100, 1998) as presentedin Table 1A, or by responsible organizations as requested bygovernmental authorities, for instance by the Life Sciences ResearchOffice (LSRO) of the American Society for Nutritional Sciences aspresented in Table 1B. The resultant infant formulas are sometimescalled “humanized milk”, “simulated human milk”, “simulated mothermilk”, “simulated breast milk” and “infant nutritional formula”.

An infant formula which contains all the essential macronutrients andmicronutrients, have heretofore been available only in shelf-stablesterilized products. Sterilized products are generally sold inhermetically sealed containers such as cans and are intended to have along room temperature shelf-life. Table 2 lists several commerciallyavailable shelf-stable sterilized infant formulas. As will be discussedfurther herein, sterilization processes, due to the severity of the heattreatment can cause undesirable physical, chemical, enzymatic andmicrobial changes which deleteriously affect the final product.

Moreover, although such sterilized products are often marketed as“ready-to-feed” (RTF), they are typically stored at room temperature,and enzymatic reactions still occur, albeit slower, during roomtemperature storage of sterilized products. Such reactions can result ina host of undesirable defects, such as the destruction of vitamins whichare necessary to the integrity of the overall product. Since sterilizedproducts are designed to have up to one and a half (1½) year of roomtemperature shelf-life, such products will have a different actualcontent of degradable micro nutrients (vitamins) in the early part ofits shelf-life as compared to the latter part. Thus, an infant willobtain a different and unknown amount of vitamins depending on when thesterilized product is consumed.

To account for this degradative process during long-term shelf-life,manufacturers of sterilized infant formulas often include up to 50% to70% more of a given vitamin than would normally be included to accountfor the inherent degradation loss and to ensure the product is likely tocontain at least the labeled amount of nutrients at the end of itsshelf-life. Such large overdosing results in an imbalance in the tasteof the product, particularly if consumed in the early stages of itsshelf-life. Moreover, the cost factor of including such large overdosesis considerable. In addition to the high cost of sterilization, andincreased overdosing of vitamins, sterilization processes require highcost packaging, such as in metal cans.

Like milk, liquid infant formulas (usually containing milk proteins andsometimes soy protein) are heated for a variety of reasons, the mainreasons being: to remove potential pathogenic organisms and to increaseshelf-life. The major concerns about the resulting products of thermalprocess are safety and quality. Like milk, heat-treated infant formulasshould not be a public heath risk. They should have a good keepingquality, provide an intended balance of nutrients, and be of desirablesensory characteristics, i.e., appearance, color, flavor, and mouthfeel. When milk or infant formulas are heated at a constant temperature,all their constituents and components will be affected, but to differentextents. Increasing the temperature will accelerate reaction rates. Butdifferent reactions will be affected to different extents. Physical,chemical, enzymatic and microbial changes will depend principally uponthe time-temperature conditions, but will also be influenced by otherfactors, such as composition, pH, and oxygen content. The wide range ofreactions taking place when infant formulas are heated will influencethe safety and quality of the product. Upon heating of products athigher temperatures for longer times, some undesirable changes can alsotake place (e.g., decrease in pH, Maillard browning, cooked caramelflavor, denaturation of whey proteins and interaction with casein). Thechanges that take place during heating and subsequent storage, canaffect the nutritional value and sensory characteristics.

In thermal processing, the most important parameter is the level ofmicrobial inactivation achieved. For safety reasons, the minimum holdingtime (residence time) should be considered for microbial inactivation,although this will give an underestimate of the true level of microbialinactivation.

In terms of microbial quality and reducing spoilage rates, the emphasisis toward that of prevention. One approach, now widely used, is that ofHazard Analysis Critical Control Points (HACCP). Here the philosophy isto identify where hazard may occur from raw materials, differentprocessing stages, packaging, or subsequent handling and storage.Critical control points are then established. These are points in theproduction process where the hazard can be effectively controlled. Lossof control permits the realization of the potential hazard as anunacceptable food safety or spoilage risk.

The quality of raw materials (ingredients) also has a pronounced effecton the quality of the final product. From the microbial point of view,the ingredients must be free of serious pathogens, and have initialtotal bacterial counts not more than 10⁴ per gram. This reflects goodhygiene in production of the ingredients. It is also useful to monitorpsychotropic bacteria in raw ingredients (via direct assay ofproteolytic enzymes) as they are usually predominant among themicroorganisms found in pasteurized products.

Sterilization (Prior Art)

The currently practiced process for preparation of infant formulas isthermal sterilization. Table 2 shows that, at the present time, thereare more than a dozen of these liquid infant formulas available in themarket. Typically, these products are commercially sterile and offeredin metal cans or heavy plastic containers and are stored at roomtemperature (i.e., they are shelf-stable). None of these infant formulasare prepared or offered as ultra-pasteurized or pasteurized product.

Sterilizing a product means exposing it to such powerful heat treatmentthat all microorganisms are killed. However, absolute sterility is notpossible. The term “Commercial Sterility” is used instead. From the U.S.regulations point-of-view (21 CFR 113.3, 1998), “Commercial Sterility”of thermally processed food means the condition achieved—

1) By the application of heat which renders the food free of—

(a) Microorganisms capable of reproducing in the food under normalnon-refrigerated conditions of storage and distribution; and

(b) Viable microorganisms (including spores) of public healthsignificance; or

2) By the control of water activity and the application of heat, whichrenders the food free of microorganisms capable of reproducing in thefood under normal non-refrigerated conditions of storage anddistribution.

It is common practice in the commercial sterilization of low-acid foods(i.e., pH>4.5) to achieve at least a 12 decimal reduction for spores ofClostridum botulinum, because they are the most heat resistant of themajor food poisoning organisms.

Two main methods are used for sterilizing liquid infant formulas:in-container sterilization, and UHT (Ultra High Temperature) treatment.For in-container sterilization, two different types of sterilizers areused: autoclaves (retorts) for batch processing, and hydrostatic towersfor continuous processing. For UHT treatment, where the product issterilized in a continuous flow followed by aseptic filling, twodifferent types of sterilizing systems are also used. One of thesemethods operates on the principle of direct steam injection or steaminfusion and the other on indirect heating in heat exchanger.

In the retort sterilization method, the infant formula is usuallypreheated and then filled into a clean can, hermetically sealed, andplaced in a steam chamber and sterilized, normally at 121° C. (250° F.)for 15-40 minutes. The batch is then cooled and the retort filled with anew batch. The fact that sterilization takes place after fillingeliminates the need for aseptic handling but, on the other hand, onlyheat resistant packaging materials can be used. In the hydrostatic towermethod of in-container sterilization, the infant formula containers areslowly conveyed through successive heating and cooling zones in thesterilizer. These zones are dimensioned to correspond to the requiredtemperatures and holding times in the various treatment stages.

In the UHT treatment, the infant formula is pumped through a closedsystem. On the way it is preheated, sterilized, homogenized, cooled, andfilled aseptically. This method is generally understood as a treatmentin which product is heated to a temperature of 135 to 150° C. in—continuous flow in a heat exchanger for a sufficient length of time toachieve commercial sterility with an acceptable amount of change in theproduct. From the U.S. regulations point-of-view (21 CFR 113.3, 1998),aseptic processing and packaging means the filling of a commerciallysterilized cooled product into pre-sterilized containers, followed byaseptic hermetical sealing, with a pre-sterilized closure, in anatmosphere free of microorganisms. Sterilization takes place at 135-150°C. (275-300° F.) for 2-5 seconds, either by means of indirect heating,direct steam injection or infusion. All parts of the system downstreamof the actual sterilization section are of aseptic design in order toeliminate the risk of reinfection.

Although bacterial enzymes do not normally survive an in-containerprocess to cause adverse effects during subsequent storage of theproduct, they will survive a UHT process to a high degree to give suchproblems as off-flavor and gelation during storage. In the absence ofsome other system for inactivating the enzyme, e.g., the low temperatureholding system (such as for ultra-pasteurized or pasteurized products),the only solution is to avoid these enzymes by careful control of theraw material to prevent the growth of the psychotropic organisms whichgive rise to these very resistant enzymes.

Aseptic filling is an integral part and a crucial step in UHT treatment.The container itself will need sterilization before filling. Cans aretypically sterilized by superheated steam. Presently, most sterilizedinfant formulas in the market are packaged in cans.

Most packages used in the UHT processes are sterilized with hydrogenperoxide at a concentration of between 20 and 35 percent and atemperature between 80 and 85° C. Residence times of several seconds arerequired. Care should be taken to ensure that all hydrogen peroxide isremoved, as it is a strong oxidizing agent. The oxygen permeability ofthe plastic is important and may well influence the shelf-life of theproduct.

Another term used in connection with UHT treatment to characterize thequality of the treatment is the “shelf-life” of the product. This isdefined as the time which the product can be stored without the qualityfalling below a certain acceptable, minimum level. The concept issubjective—the shelf-life can be very long if the criteria of productquality are low. The physical and chemical limiting factors ofshelf-life are gelling, increase of viscosity, sedimentation, and phaseseparation. The organoleptic limiting factors are deterioration oftaste, smell, and color.

There is a need for a refrigerated ready-to-feed or concentrated infantformulas that do not suffer from the disadvantages of sterilizedproducts. Such infant formulas should include all the required nutrientsas listed in Table 1A or Table 1B, should be organoleptically pleasing,have a shelf-life of between about 1 and 16 weeks and use the simple andinexpensive processing of pasteurization or ultra-pasteurization.Moreover, there is a need for cost effective ready-to-feed andconcentrated infant formula which can be refrigeration-stored ininexpensive packaging, such as gable top cartons or plastic containerstraditionally used in milk products.

The present invention meets these and other needs, as will come apparentin the description provided below.

THE SUMMARY OF THE INVENTION

The present invention relates to refrigeration-shelf-stableready-to-feed and concentrated complete infant formulas which have beeneither ultra-pasteurized or pasteurized and which are designed toinclude per 100 kilocalories the specified nutrients (Table 1B). Therefrigerated infant formulas are refrigeration-shelf-stable products.The compositions of the present invention can optionally includenon-essential but nutritionally desirable and functional components.

In one embodiment, the present invention includes refrigerationshelf-stable ready-to-feed (RTF) or concentrated infant formula beingthermally treated under conditions of ultra-pasteurization orpasteurization comprising, per 100 kilocalories: from about 4.4 to about6.4 grams of total fat; linoleic acid from about 8 to about 35 percentof total fat on weight basis; α-linolenic acid from about 1.75 to about4 percent of total fat on weight basis; from about 1.7 to about 3.4grams of protein; from about 1.2 to about 2 mg of Carnitine; from about0 to about 12 mg of Taurine; from about 0 to about 16 mg of Nucleotides;from about 7 to about 30 mg of Choline; from about 4 to about 40 mg ofInositol; from about 9 to about 13 grams of carbohydrate; from about 50to 140 mg of Calcium; from about 20 to about 70 mg of Phosphorus; fromabout 4 to about 17 mg of Magnesium; from about 0.2 to about 1.65 mg ofIron; from about 0.4 to about 1 mg of Zinc; from about 1 to about 100mcg of Manganese; from about 60 to about 160 mcg of Copper; from about 8to about 35 mcg of Iodine; from about 25 to about 50 mg of Sodium; fromabout 60 to about 160 mg of Potassium; from about 50 to about 160 mg ofChloride; from about 1.5 to about 5 mcg of Selenium; from about 0 toabout 60 mcg of Fluoride; from about 200 to about 500 IU of Vitamin A;from about 40 to about 100 IU of Vitamin D; from about 0.5 to about 5.0mg of Vitamin E per gram of polyunsaturated fatty acids, wherein saidpolyunsaturated fatty acids are from about 0.4 to about 2.5 grams; fromabout 1 to about 25 mcg of Vitamin K; from about 30 to about 200 mcg ofThiamine or Vitamin B1; from about 80 to about 300 mcg of Riboflavin orVitamin B2; from about 550 to about 2000 mcg of Niacin; from about 30 toabout 130 mcg of Vitamin B6; from about 0.08 to about 0.7 mcg of VitaminB 12; from about 11 to about 40 mcg of Folic Acid or Folacin; from about300 to about 1200 mcg of Pantothenic Acid; from about 1 to about 15 mcgof Biotin; and from about 6 to about 15 mcg of Vitamin C or AscorbicAcid; wherein the total caloric content is from about 80 kilocalories toabout 300 kilocalories per 150 milliliters or 5 fluid ounces.

The compositions of the present invention are designed to berefrigeration shelf-stable at temperatures of about 1° C. to 7° C. andpreferably about 2° to about 3° C. These are conventional refrigerationtemperatures for dairy products. Shelf-life for pasteurized compositionsof the present invention will generally be up to about 2 weeks, and forultra-pasteurized compositions of the present invention, the shelf-lifewill be between about 4 to about 16 weeks.

The refrigerated storage will preserve the overall quality ofultra-pasteurized and pasteurized compositions of the present inventionbetter than room-temperature storage can preserve the quality ofcommercially available sterilized room temperature shelf-stableproducts. This is because the rate of all physical, chemical, andenzymatic reactions during storage are decreased at the lowertemperatures. Because of the lower initial vitamins and less degradationduring low temperature storage, the undesirable off-taste of vitaminsare less pronounced in refrigerated products, making themorganoleptically more acceptable than non-refrigerated/shelf-stableproducts and ensuring these components are delivered in the labeledamount to the infants.

Unlike UHT-sterilized non-refrigerated/shelf-stable products describedherein, bacterial enzymes (protease and lipases) which may be present inthe compositions of the present invention cause minimal adverse effects,if any, at conventional dairy refrigeration temperatures. However, inUHT-sterilized non-refrigerated/shelf-stable products, bacterial enzymescan cause off-flavor (astringent, bitterness), and thickening orgelation during storage.

Prolonged storage of sterilized products at temperatures exceedingapproximately 30.5° C. (85° F.), can also cause activation ofheat-sensitive spores that are not destroyed by usual heat sterilizationduring manufacturing. At refrigerated storage temperature(s) used forthe present inventive concept, especially for relatively short times (1to 16 weeks), there is much less risk of such a problem.

Compared to sterilized non-refrigerated/shelf-stable products, the costof vitamin components is lower in the refrigerated shelf-stablecompositions of the present invention. This is because there will beless degradation of vitamins at the refrigerated temperature of storage,as well as shorter storage time (up to 16 weeks versus up to 1.5 year),and therefore less requirement for overdosing of the vitamins in theformulation. Furthermore, since production of the inventive refrigeratedpasteurized or ultra-pasteurized infant formulas will be done in theestablished dairy factories, usually as “piggyback products”, where nocapital investment is required, the cost of such production will bereasonably low. The cost of packaging of the compositions and productsof the present invention is significantly lower than the cost of cansused in sterilization processes. The refrigerated distribution and saleof the infant formulas will also be done as a piggyback to dairyproducts, also making the distribution cost tolerable. The overallproduct cost of products made from the present invention will besignificantly less than the cost of the sterilizednon-refrigerated/shelf-stable products currently in existence.

Ultra-pasteurization and pasteurization are versatile technologies thatare used in every developed and most developing countries. Refrigeratedpasteurized and/or ultra-pasteurized infant formulas, prepared throughthese versatile technologies, can therefore easily be made locallyavailable at all markets of the world, contributing to the improvedhealth and nutritional status of healthy and sick infants.

Unlike regular sterilized non-refrigerated/shelf-stable products, wherethe primary container is a metal can, the primary container forrefrigerated products of this invention is a gable top carton or plasticbottle. Compared to cans, gable top cartons and plastic bottles arelighter, take up less storage space in production plants, are moreenvironmentally friendly, and have built-in reclosable pour spouts.

The food industry, as distinct from the infant nutrition industry, hasprimarily used ultra-pasteurization and pasteurization processes and hasnot been familiar with the more advanced and sophisticated sterilizationprocesses used by the infant nutrition industry. For example, in infantformulas, the concentration of every single added vitamin must becalculated in a way that the effect of heat treatment and storage doesnot affect the label claim concentration of such vitamin. Table 6 showsthe source and quantity of each vitamin added to form the inventivenutritional infant formula. Likewise, the concentration of every singleadded mineral must be calculated in a way that contribution of the samemineral from other ingredients does not affect the label claimconcentration of such mineral. Table 7 shows the source and quantity ofeach mineral added to form the inventive standard infant formula. Suchvitamin and mineral sources can be individually prepared as premixes foruse with the inventive standard infant formula. As used herein, the term“premix” and its variants refer to ingredients that may be combined toform a constituent element of the infant formula of the presentinvention.

Although ultra-pasteurization and pasteurization have been usedextensively for the preparation of refrigerated dairy products, no onehas used these processes to prepare refrigerated pasteurized and/orultra-pasteurized ready-to-feed or concentrated infant formulas.Compositions of the present invention can be used to supplement orsubstitute breast milk. The refrigerated ready-to-feed or concentratedproducts of the present invention are nutritionally complete and dosatisfactorily meet the complete nutritional needs (including allnecessary vitamins and minerals) of healthy infants, as set forth bygovernmental regulations, such as U.S. federal regulations (21 CFR107.100, 1998).

DETAILED DESCRIPTION OF THE INVENTION

Definitions

Infant Formula

The term “infant formula” is not specifically defined as a regulatorydefinition. An infant formula, when in liquid form, may be used eitherdirectly or diluted with safe, potable, and previously boiled waterbefore feeding, as appropriate. Infant formula should also benutritionally adequate to promote normal growth and development whenused in accordance with its directions for use. Infant formula shouldalso be processed by physical means only and so packaged as to preventspoilage and contamination under all normal conditions of handling,storage and distribution in the country where the product is sold.

Infant formulas are liquids or reconstituted powders fed to infants andyoung children. They serve as substitutes for human milk. Infantformulas have a special role to play in the diets of infants becausethey are often the only source of nutrients for infants. For thisreason, the composition of commercial formulas is carefully controlledand is required to meet very strict standards. For purpose of thepresent invention, the term “infant formula” means a composition thatsatisfies the nutrient requirements of an infant by being a substitutefor human milk. Current U.S. federal regulations state that an infantformula shall contain nutrients, as listed in Table 1A, at a level notless than the minimum level specified and not more than the maximumlevel specified for each 100 kilocalories of the infant formula in theform prepared for consumption. (21 CFR 107. 100, 1998). The regulationsset macronutrient, essential vitamin and mineral levels in an effort tosimulate the nutritional properties of human milk.

Furthermore, from the U.S. regulations point-of-view 21 CFR 107.100provides the following should also apply to infant formulas. Vitamin Eshall be present at a level of at least 0.7 International Unit ofvitamin E per gram of linoleic acid. Any vitamin K added shall be in theform of phylloquinone. Vitamin B₆ shall be present at a level of atleast 15 micrograms of vitamin B₆ for each gram of protein in excess of1.8 grams of protein per 100 kilocalories of infant formula in the formprepared for consumption as directed on the container. The ratio ofcalcium to phosphorus in infant formula in the form prepared forconsumption as directed on the container shall be no less than 11. andnot more than 2.0. Protein shall be present in an amount not to exceed4.5 grams per 100 kilocalories regardless of quality, and not less than1.8 grams per 100 kilocalories of infant formula in the form preparedfor consumption as directed on the container when its biological qualityis equivalent to or better than that of casein. If the biologicalquality of the protein is less than that ol casein, the minimum amountof protein shall be increased proportionately to compensate for itslower biological quality. For example, an infant formula containingprotein with a biological quality of 75 percent of casein shall containat least 2.4 grams of protein (1.8/0.75). No protein with a biologicalquality less than 70 percent of casein shall be used.

Alternatively, from a second point-of-view, an infant formula shallcontain nutrients, as listed in Table 1B, at a level not less than theminimum level specified and not more than the maximal level specifiedfor each 100 kilocalories of the infant formula in the form prepared forconsumption. (Proposed LSRO-1998 Recommendation).

Furthermore, proposed LSRO-1998 Recommendation provides the followingshould also apply to infant formula. The calcium to phosphorus ratioshall not be less than 1.1 and not more than 2.0. The minimum proteincontent is expressed in terms of α-amino nitrogen (true protein) times6.25. Useful amino acid levels are listed in Table 1C. The energycontent should be from about 63 to about 71 kcal/deciliter. Thealpha-linolenic acid should from about 0.077 to about 0.256 grams. Thelinoleic/alpha-linolenic acid ratio should be from about 6:1 to about16:1. Vitamin E should be from about 0.5 mg/g of PUFA to about 5.0 mg/gof PUFA.

PUFA are polyunsaturated fatty acids, such as linoleic acids, linolenicacids, arachidonic acid and the like. Furthermore, PUFA is part of thefat content and the level of PUFA in the fat content depends upon thesource of the fat or oil used in the infant formula.

Moreover, during illness, water loss of an infant is often increasedbecause of fever. Because the intake of formula during illness isusually decreased, a renal solute load can be an importantconsideration. Consequently, an infant formula should consider thepotential renal (kidney) solute load (PRSL). The potential renal soluteload can be estimated as follows:

PRSL=N/28+Na+Cl+K+P_(a),

Where N is nitrogen in mg, Na is sodium in mg, Cl is chloride in mg, Kis potassium in mg, and Pa is available phosphorus (nonphytatephosphorus) in mg. The maximum value of PRSL is expressed in terms ofmmol or mosol as shown below.

Component mg/100 kcal mosmol/100 kcal Nitrogen 540 19.4 Sodium 50 2.2Chloride 160 4.6 Potassium 160 4.1 Available Phosphorus 70 2.3 32.6

Furthermore, according to 21 CFR 107.20 the label of the infant formulashould bear: (21 CFR 107.20(c), 1998). “Use by ” date, the blank to befilled in with the month and year selected by the manufacturer, packer,or distributor of the infant formula on the basis of tests or otherinformation showing that the infant formula, until that date, under theconditions of handling, storage, preparation, and use prescribed bylabel directions, will: (1) when consumed, contain not less than thequantity of each nutrient, as set forth on its label; and (2) otherwisebe of an acceptable quality (e.g., pass through an ordinary bottlenipple).

The infant formula of the present invention may be ready-to-feed (RTF).As used herein the term “ready-to-feed” refers to a formula which may beconsumed without requiring additional compositional changes prior toconsumption. For example, a RTF infant formula may be consumed by aninfant without having to mix water or another fluid to form a properlyinfant drinkable formula, such as the case with powdered mixes.

The infant formula of the present invention may not be ready-to-feed andmay require some preparation for use by the consumer. For example, aconcentrated form of a liquid formula may require dilution with waterprior to consumption by the infant. Standard dilution from a U.S.regulations point-of-view is defined as equal amounts of concentratedliquid and water (21 CFR 107.20(b), 1998). As used herein, the term“concentrated” and its variants refer to a concentrated infant formulawhich upon dilution with water results in the mixture meeting thenutrient specifications regulated for infant formula.

In addition, some non-required, but valuable nutritional or functionalcompounds (such as taurine; L-carnitine; beta-carotene; nucleotides,such as cytidine 5′-monophosphate, disodium uridine 5′-monophosphate,disodium guanosine 5′-mnonophosphate and adenosine 5′-monophosphate;emulsifiers, stabilizers, natural color, natural flavor, etc.) can beadded to the formulation of infant formulas.

Ultra-Pasteurization

The first alternative process for preparation of refrigeratedcompositions of the present invention, and particularly in the form ofready-to-feed and concentrated infant formulas, is thermalultra-pasteurization.

From the U.S. regulation point-of-view (21 CFR 131.3, 1998),Ultra-pasteurization (UP) when used to describe a dairy product meansthat such product shall have been thermally processed at or above 280°F. for at least 2 seconds, either before or after packaging, so as toproduce a product which has an extended shelf-life under refrigeratedconditions.

Comparison of the regulatory definition for ultra-pasteurization withthe regulatory definition for aseptic processing and packaging clarifiesthat while ultra-pasteurized products are thermally sterilized, theyshould be stored under refrigerated condition. In fact storagetemperature of sterilized nutritional products (room temperature) andultra-pasteurized nutritional products (refrigerated temperature) is animportant distinction between products prepared by these two processes.

The containers for packaging of liquid infant formulas and products,through the production and distribution network, must also meet certainrequirements. The shape and presentation must be attractive, provideeffective protection against impact, light, and heat, and be easy toopen. They also must protect the product from contamination by foreignflavors or odors, be easy to carry, non-returnable (one-way),environmentally friendly, reasonably priced, and well adapted to modernproduction needs. At the present time, “Gable Top Cartons” are thepackaging of choice for liquid dairy products and the preferredpackaging to the present invention because they meet all of the aboverequirements. They have better handling and a built-in reclosable pourspout. They are lightweight but rugged and shatterproof. They areconvenient, easily disposable, and almost universally available. Gabletop carton unformed flat blanks save valuable warehouse storage space.

Structurally, gable top cartons are made of cardboard lined withpolyethylene and are generally preassembled in the plant. In order tomeet certain particular requirements, more sophisticated manufacturingmethods are sometimes required; for example, a thin layer of aluminummay be used to line the interior walls of the container to provide aneffective barrier against oxygen penetration and provide betterconservation.

Alternatively, the ultra-pasteurized and pasteurized infant formulas andproducts of the present invention may also be packaged in other type ofcontainers such as plastic containers.

The refrigerated storage will preserve the quality of ourultra-pasteurized products better than room-temperature storage canpreserve the quality of commercially available sterilizednon-refrigerated/shelf-stable products. As previously mentioned,prolonged storage of sterilized canned products at temperaturesexceeding approximately 30.5° C. (85° F.), can cause activation ofheat-sensitive spores that are not destroyed by usual heat sterilizationduring manufacturing. See “Preventing Microbial Contamination of EnteralFormulas and Delivery System”, Ross Product Division, AbbottLaboratories, Columbus, Ohio April 1996. Moreover, protease and lipaseenzymes, produced by psychotropic bacteria, are markedly heat resistantand readily withstand UHT sterilization. Heat-stable enzymes are oflimited importance in the spoilage of ultra-pasteurizedrefrigeration-shelf-stable products. These enzymes are, however,associated with age thickening or gelation in UHT products stored atroom temperature. Thickening may be accompanied by the development ofoff-flavors, the “astringent” defect being attributed to polypeptidesresulting from the breakdown of casein. Bitter flavors also develop as aresult of the activity of heat-stable microbial proteases. Heat-stablelipases are not involved in structural changes but activity leads to anincrease in fatty acid content of the product and acidic off-flavors.

The compositions of the present invention are designed to berefrigeration shelf-stable, i.e., at temperatures of about 1° C. to 7°C. and preferably about 2° to about 3° C. These are conventionalrefrigeration temperatures for dairy products. Shelf-life forpasteurized compositions of the present invention will generally be upto about 2 weeks, and for ultra-pasteurized compositions of the presentinvention, the shelf-life will be between about 4 to about 16 weeks.

The refrigerated storage will preserve the overall quality ofultra-pasteurized and pasteurized compositions of the present inventionbetter than room-temperature storage can preserve the quality ofcommercially available sterilized room temperature shelf-stableproducts. This is because the rate of all physical, chemical, andenzymatic reactions during storage are decreased at the lowertemperatures. Because of the lower initial vitamins and less degradationduring low temperature storage, the undesirable off-taste of vitaminsare less pronounced in refrigerated products, making themorganoleptically more acceptable than non-refrigerated/shelf-stableproducts and ensuring these components are delivered in the labeledamount to the infants. As shown in Table 6, only an excess of about tento twenty percent of a vitamin (excluding heat-labile vitamin C) isrequired to deliver the labeled quantity of the vitamin, and such excessquantity of the present invention is often substantially lower ascompared to other available infant formulas.

Pasteurization

The second alternative process for the preparation of refrigeratedcompositions of the present invention is thermal pasteurization.

The International Dairy Federation has defined pasteurization (P) as aprocess applied to a product with the objective of minimizing possiblehealth hazards arising from pathogenic microorganisms associated withmilk, by heat treatment, which is consistent with only minimal chemical,physical, and organoleptic changes in the product. For purposes of thepresent invention, pasteurization will have this meaning.

From the U.S. regulation point-of-view (21 CFR 131.3, 1998), the term“pasteurized” when used to describe a dairy product means that everyparticle of such product shall have been heated in properly operatedequipment to one of the temperatures specified in the table below andheld continuously at or above that temperature for the specified time(or other time/temperature relationship which has been demonstrated tobe equivalent thereto in microbial destruction):

Temperature Time 145° F.¹ 30 minutes 161° F.¹ 15 seconds 191° F. 1second 204° F. 0.05 second 212° F. 0.01 second ¹If the dairy ingredienthas a fat content of 10 percent or more, or if it contains addedsweeteners, the above specified temperature is increased by 5° F.

The main purpose of pasteurization is the thermal killing of pathogenswhich are the microorganisms causing disease in humans. Pasteurizedproducts must be entirely free from pathogens. In fact, pasteurizationof milk is required by law in most countries. The traditional pathogensin raw milk are Mycobacterium bovis which causes bovine tuberculosis(which also affects humans), Brucella abortus which transmitsbrucellosis (undulant fever) to man, Salmonella which are responsiblefor gastrointestinal diseases and typhoid fevers and Campylobacterjejuni, a common factor in enteritis.

Apart from pathogenic microorganisms, nutritional products or milk alsocontains other substances and microorganisms which may spoil the tasteand shelf-life of the product. A secondary purpose of pasteurization istherefore to destroy as many as possible of these other organisms andenzymatic systems in order to safeguard product quality. This requiresmore intensive heat treatment than is necessary to kill the pathogenicbacteria.

To ensure the destruction of all pathogenic microorganisms, it isnecessary to heat the product to a given temperature and hold it at thattemperature for a certain length of time before it is cooled again. Thecombination of temperature and holding time is very important as itdetermines the intensity of the heat treatment.

Intensive heat treatment of product is desirable from themicrobiological point of view. But such treatment also involves a riskof adverse effects on the appearance, taste and nutritional value of theproduct. The choice of time/temperature combination is therefore amatter of optimization in which both microbiological effects and qualityaspects must taken into account.

The original type of pasteurization was a batch process (also called LowTemperature Long Time, LTLT). The milk was heated to 63° C. in open vatsand held at that temperature for 30 minutes. Nowadays pasteurization isalmost always in the continuous HTST (High Temperature Short Time)process. The main advantages of HTST pasteurization is its capacity toheat-treat milk quickly and adequately while maintaining rigidbacteriological and quality control.

The actual time/temperature combination varies according to the qualityof the raw materials, the type of product treated, and the requiredkeeping properties. The combination of higher temperatures and longertimes are recommended for HTST pasteurization of products with a highercontent of solids. Thus, for pasteurized cream of 18% fat, thespecifications are 75° C. for 15 seconds, for cream of 35% fat, 80° C.for 15 second, and for pasteurized concentrated milk (similar to infantformula products of the present invention), 80° C. for 25 seconds.

The function of each nutrient in a system not only depends on thegeneral conditions of the system (e.g., temperature and pH), but also toa great extent on the presence or absence of other nutrients. This isbecause each new nutrient functions like a new chemical entity that canreact with other nutrients in the system. These new reactions caninclude degradation of vitamins, precipitation of minerals, denaturationand crosslinking proteins, changes in hydrocolloidal behavior ofcarbohydrates, phase separation of the system, changes of sensoryprofile, and changes in nutritional bioavailability of the system.

Pasteurization and ultra-pasteurization may also be accomplished usingohmic or microwave heating.

The compositions of the present invention have been formulated such thatthe resultant pH is essentially neutral, e.g., about 5.5 to about 7.5.Preservation of the inventive compositions is accomplished bypasteurization and ultra-pasteurization methods and is not dependent onacidic pH for preservation.

The fat source or premix of the formulations may be any fat source orcombination of fat sources which provide the desired amount of fatcalories. Preferably, the fat source should be high in monounsaturatedfatty acids. Fat sources may include vegetable oils, e.g., high oleicacid vegetable oils such as sunflower oil, canola oil and olive oil;safflower oil, coconut oil, cottonseed oil, corn oil or soybean oil, andmedium chain triglycerides, e.g., C₆-C₁₂ triglycerides, and short chaintriglycerides. In addition, butter fat and other types of oils may beused. The protein source or premix may be selected from a variety ofmaterials, including without limitation, milk protein, whey protein,caseinate, soy protein concentrate, soy protein isolate, egg protein,gelatin, collagen and combinations thereof. For lactose-free infantformula soy protein can be used. Alternatively lactose-free skim milk(produced by hydrolyzing the lactose by lactase enzymes to glucose andgalactose, or other method) can suitably be used.

Included in the protein source are lactose-free skim milk, milk proteinisolate, and whey protein isolate. The milk can be selected from a groupof animals consisting of cow, sheep, goat, buffalo, camel, llama, mare,deer and combinations thereof. Furthermore, the milk used in the presentinvention may be organic milk. As used herein, the term “organic” refersto a food, such as a milk, produced without the use of pesticides,chemical fertilizers, herbicides or fungicides. Typically, land on whichmilk-producing animals are raised and grains or grasses used to feedthese animals should be free of these prohibited substances, e.g.,pesticides, chemical fertilizers, herbicides or fungicides, for a numberof years, often three years, prior to the milk being labeled as organic.Such organic milk is usually produced from animals that aresubstantially free of synthetic hormones, such as recombinant bovinesomatotropin hormone (rbST/rBGH), and antibiotics.

When the composition is used as hypoallergenic infant formula, theprotein source can also include enzymatically-hydrolyzed protein(peptides), amino acids and combinations thereof.

The amount of protein in five fluid ounces is about 1.7 to 3.4 grams.The energy contained in five fluid ounces of compositions of the presentinvention in the form prepared for consumption is intended to be about100 kilo calories.

The carbohydrate source or premix useful in the present invention may beselected from a wide variety of materials such as lactose, sucrose, cornsyrup solids, dextrose, glucose, fructose, honey, rock candy,maltodextrin and combinations thereof.

Artificial sweeteners such as saccharine, aspartame, asulfame K,sucrolose and their combination, as well as others, may be incorporatedto enhance the organoleptic and sweetness quality of the compositions.Various fiber sources may be included in the compositions of the presentinvention. These sources may be selected from such materials as oatfiber, soy fiber, guar gum, pectin, soy polysaccharides, gum arabic,hydrolyzed fibers and the like. Cellulose, hemicellulose, hydrocollides,methylcellulose, carboxymethylcellulose and the like are contemplated.Also useful are fructo-oligosaccharides.

Compositions of the present invention can be formulated into a varietyof different product forms. For example, a standard ready-to-feedcomposition is one such form of infant formula. Other forms includeexempt infant formula, concentrated, lactose-free, high protein,fiber-containing, high carbohydrate, soy-based and hypoallergenic. In apreferred embodiment, the present invention includes arefrigeration-shelf-stable ready-to-feed infant formula being thermallytreated under conditions of pasteurization or ultra-pasteurizationcomprising, having from about 80 to about 300 kilocalories per fivefluid ounces and having sufficient nutrients, vitamins and minerals asregulated for infant formula.

In a desirable aspect, the present invention includes refrigerationshelf-stable ready-to-feed (RTF) or concentrated infant formula beingthermally treated under conditions of ultra-pasteurization orpasteurization comprising, per 100 kilocalories: from about 4.4 to about6.4 grams of total fat; linoleic acid from about 8 to about 35 percentof total fat on weight basis; α-linolenic acid from about 1.75 to about4 percent of total fat on weight basis; from about 1.7 to about 3.4grams of protein; from about 1.2 to about 2 mg of Carnitine; from about0 to about 12 mg of Taurine; from about 0 to about 16 mg of Nucleotides;from about 7 to about 30 mg of Choline; from about 4 to about 40 mg ofInositol; from about 9 to about 13 grams of carbohydrate; from about 50to 140 mg of Calcium; from about 20 to about 70 mg of Phosphorus; fromabout 4 to about 17 mg of Magnesium; from about 0.2 to about 1.65 mg ofIron; from about 0.4 to about 1 mg of Zinc; from about 1 to about 100mcg of Manganese; from about 60 to about 160 mcg of Copper; from about 8to about 35 mcg of Iodine; from about 25 to about 50 mg of Sodium; fromabout 60 to about 160 mg of Potassium; from about 50 to about 160 mg ofChloride; from about 1.5 to about 5 mcg of Selenium; from about 0 toabout 60 mcg of Fluoride; from about 200 to about 500 IU of Vitamin A;from about 40 to about 100 IU of Vitamin D; from about 0.5 to about 5.0mg of Vitamin E per gram of polyunsaturated fatty acids, wherein saidpolyunsaturated fatty acids are from about 0.4 to about 2.5 grams; fromabout 1 to about 25 mcg of Vitamin K, from about 30 to about 200 mcg ofThiamine or Vitamin B l; from about 80 to about 300 mcg of Riboflavin orVitamin B2; from about 550 to about 2000 mcg of Niacin; from about 30 toabout 130 mcg of Vitamin B6; from about 0.08 to about 0.7 mcg of VitaminB 12; from about 11 to about 40 mcg of Folic Acid or Folacin; from about300 to about 1200 mcg of Pantothenic Acid; from about 1 to about 15 mcgof Biotin; and from about 6 to about 15 mcg of Vitamin C or AscorbicAcid; wherein the total caloric content is from about 80 kilocalories toabout 300 kilocalories per 150 milliliters or fluid ounces.Alternatively, the infant formula can be made without ironfortification, e.g., without addition of an iron source such as ferroussulfate.

Nucleotides include cytidine 5′-monophosphate, disodium uridinemonophosphate, disodium guanosine 5′-monophosphate, adenosine5′-monophosphate and the like.

Antioxidants useful in the present invention include, withoutlimitation, butylhydroxy anisole (BHA), butylhydroxy toluene (BHT),tertiary butyl hydroquinone (TBHQ), propyl gallate and combinationsthereof. Natural antioxidants can also be included through additionalamounts of vitamin C, E, beta-carotene, selenium, zinc and combinationsthereof. Various herbs, herb extracts, botanicals, botanical extracts,amino acids and the like, and combinations thereof, can also be includedfor their intended functions and various products using such dietarysupplements can be formulated therefrom.

Various non-nutritive components can be included in the inventivecompositions. For example, fillers, thickeners (e.g., carrageenan),natural colors, natural flavors, emulsifiers (e.g., soy lecithin),stabilizers and the like are useful.

Various nutraceuticals and phytochemicals can be incorporated into theinventive compositions for their intended function and as a treatmentfor infants with specific disorders. The standard formulation as setforth in the Table 3 can be augmented with a variety of additionalcomponents to specially tailor the composition as an exempt infantformula. Various specialized products can be formulated. For examplewhen the composition is to be used as a food for special dietary use, itcan be formulated into a hypoallergenic infant formula that containshydrolyzed proteins. Other foods for special dietary use include infantwho have inborn errors of metabolism or low birth weight, or who haveotherwise have unusual medical or dietary problems. As used herein, theterm “exempt infant formula” means an infant formula which isrepresented and labeled for use by an infant who has an inborn error ofmetabolism or low birth weight or who otherwise has an unusual medicalor dietary problem, where the infant formula complies with regulations,e.g., 21 CFR 107.50, 1998, as prescribed for such exempt infantformulas.

The compositions of the present invention are intended to be stored atrefrigerated temperatures in standard gable top cartons, plasticcontainers or the like.

EXAMPLES

Batching and Processing Procedure:

Proper batching is of utmost importance. For preparation of allpasteurized and/or ultra-pasteurized infant formulas, the totalprocessing system was cleaned (CIP=Clean-In-Place).

For the preparation of all pasteurized and/or ultra-pasteurized infantformulas, high quality, food-grade ingredients were used. Order ofaddition of ingredients, their physical structure, temperature, and rateof addition are also very important.

Water was the first ingredient to be introduced into the batchingcontainer. Although the batch volume could be adjusted at the end of thebatching process, it is preferred that the amount of water isprecalculated in a way that addition of other ingredients automaticallybrings the volume of the batch to the desirable level. Next, nonfat milkis introduced into the batching container.

Proteins, fats, carbohydrates, minerals, vitamins, nucleotides and otherdesirable ingredients are added sequentially. After the addition of eachingredient, the composition was thoroughly mixed before the nextingredient was added to the system.

Upon obtaining a homogeneous batch of unprocessed infant formula withdesirable profile of nutrients and functional ingredients, the batch isimmediately pasteurized (85° C. for 30 seconds) and/or ultra-pasteurized(135-150° C. for up to 5 seconds). The pasteurized and/orultra-pasteurized infant formula is promptly cooled, and continuouslykept at refrigerated temperature (1-7° C., preferably 2-3° C.).

Example 1A

Pursuing the batching and processing guidelines explained above, and asfurther detailed in Table 4 the inventive refrigerated ready-to-feed(RTF) pasteurized and/or ultra-pasteurized infant formulas weredeveloped. Vitamins and minerals are added per Guidelines in Tables 6and 7. The ingredients, premixes, batching conditions and processconditions are shown below in Tables 8 and 9.

Example 1B

Pursuing the batching and processing guidelines explained above, and asfurther detailed in Table 4 the inventive refrigerated ready-to-feed(RTF) pasteurized and/or ultra-pasteurized infant formulas weredeveloped. Vitamins and minerals are added per guidelines in Tables 6and 7. The ingredients, premixes, batching conditions and processconditions are shown below in Tables 10 and 11.

Example 2A

Pursuing the batching and processing guidelines explained above, and asfurther detailed in Table 5 the inventive refrigerated, concentrated,pasteurized and/or ultra-pasteurized infant formulas were developed.Vitamins and minerals are added per guidelines in Tables 6 and 7. Theingredients, premixes, batching conditions and process conditions areshown below in Tables 12 and 13. After standard dilution by the consumer(equal amounts of concentrated infant formula and water), thenutritional profile of the product is identical to the RTF infantformula.

Example 2B

Pursuing the batching and processing guidelines explained above, and asfurther detailed in Table 5 the inventive refrigerated, concentrated,pasteurized and/or ultra-pasteurized infant formulas were developed.Vitamins and minerals are added per guidelines in Tables 6 and 7. Theingredients, premixes, batching conditions and process conditions areshown below in Tables 14 and 15. After standard dilution by the consumer(equal amounts of concentrated infant formula and water), thenutritional profile of the product is identical to the RTF infantformula.

Although this invention has certain preferred embodiments, it will beobvious to those skilled in the art that various changes andmodifications may be made therein without departing from the invention,and all such changes and modifications are intended to fall within thetrue spirit and scope of the invention.

TABLE 1A Nutrient Specification of Infant Formula in the Form Preparedfor Consumption According to the Code of Federal Regulations. (21 CFR107.100, 1998) Per 100 kilocalories (5 fl oz) Code of Fed. RegulationsUnit of MINIMUM MAXIMUM REQUIRED NUTRIENTS Measurement LEVEL LEVELProtein g 1.8 4.5 Fat g 3.3 6 Percent Calories 30 54 Carbohydrate gWater g Linoleic acid mg 300 Percent Calories 2.7 Vitamins: Vitamin A IU250 750 Vitamin D IU 40 100 Vitamin E IU 0.7 Vitamin K mcg 4 Thiamine(Vitamin B1) mcg 40 Riboflavin (Vitamin B2) mcg 60 Vitamin B6 mcg 35Vitamin B12 mcg 0.15 Niacin mcg 250 Folic acid (Folacin) mcg 4Pantothenic acid mcg 300 Biotin mcg 1.5 Vitamin C (Ascorbic Acid) mg 8Choline mg 7 Inositol mg 4 Minerals: Calcium mg 60 Phosphorus mg 30Magnesium mg 6 Iron mg 0.15 3 Zinc mg 0.5 Manganese mcg 5 Copper mcg 60Iodine mcg 5 75 Sodium mg 20 60 Potassium mg 80 200 Chloride mg 55 150

TABLE 1B Nutrient Specification of Infant Formula in the Form Preparedfor Consumption According to the Life Sciences Research Office (LSRO),1998, Per 100 kilocalories (or approximately 150 ml or 5 fluid ounces)Nutrients Unit MINIMUM MAXIMUM Energy kcal/dL 63 71 Total Fat g 4.4 6.4Total Fat as Percent of % of Energy 40 57.2 Energy Essential FatsLinoleic acid % of Total Fat 8 35 α-Linolenic acid % of Total Fat 1.754.0 Linoleic acid to ratio 16:1 6:1 α-Linolenic acid Protein g 1.7 3.4Carnitine mg 1.2 2.0 Taurine mg 0 12 Nucleotides mg 0 16 Choline mg 7 30Inositol mg 4 40 Total Carbohydrate g 9 13 Minerals: Calcium mg 50 140Phosphorus mg 20 70 Magnesium mg 4 17 Iron mg 0.2 1.65 Zinc mg 0.4 1.0Manganese mcg 1.0 100 Copper mcg 60 160 Iodine mcg 8 35 Sodium mg 25 50Potassium mg 60 160 Chloride mg 50 160 Selenium mcg 1.5 5.0 Fluoride mcg0 60 Vitamins: Vitamin A IU 200 500 Vitamin D IU 40 100 Vitamin E mg/gPUFA 0.5 5.0 Vitamin K mcg 1 25 Thiamine (Vitamin B1) mcg 30 200Riboflavin (Vitamin B2) mcg 80 300 Niacin mcg 550 2000 Vitamin B6 mcg 30130 Vitamin B12 mcg 0.08 0.7 Folic acid (Folacin) mcg 11 40 Pantothenicacid mcg 300 1200 Biotin mcg 1.0 15 Vitamin C (Ascorbic Acid) mg 6 15

TABLE 1C Essential amino acids Content (mg/100 kcal) Amino Acid MinimumMaximum Isoleucine 88 176 Leucine 171 342 Lysine 124 248 Methionine +Cysteine 58 116 Phenylalanine + Tyrosine 133 266 Threonine 77 154Tryptophan 26 52 Valine 90 180

TABLE 2 Examples of Commercially Available Shelf Stable SterilizedReady-To-Feed and Concentrated Infant Formula with and/or Without IronCompany Product (s) STANDARD FORMULA Ross Similac ® Mead JohnsonEnfamil ®, Next Step ® Wyeth-Ayerst SMA ® Gerber Gerber ® Formula Nestle(Carnation) Follow-Up ™ SOY & HYDROLYZED INFANT FORMULA Ross Isomil ®Soy Formula, Alimentum ® Protein Hydrolzate, Isomil ®/DF, Similac ® PM60/40 Mead Johnson ProSobee ® Soy, Nutramigen ® Protein Hydrolyzate,LactoFree ®, Pregestimil ® Wyeth-Ayerst Nursoy ® Nestle (Carnation) GoodStart ®, Alsoy ®

TABLE 3 Nutritional Composition of Ultra-Pasteurized (UP) or Pasteurized(P) Ready-To-Feed (RTF) Infant Formula with Iron in Comparison to theCode of Federal Regulations. Per 100 kilocalories (5 fl oz) Standard RTFCode of Fed. Regulations Unit of MINIMUM MAXIMUM Refrigerated UP of PREQUIRED NUTRIENTS Measurement LEVEL LEVEL Infant Formula Protein g 1.84.5 2.1 Fat g 3.3 6 5.3 Percent Calories 30 54 Carbohydrate g 10.9 Waterg 134 Linoleic acid mg 300 1000 Percent Calories 2.7 Vitamins: Vitamin AIU 250 750 300 Vitamin D IU 40 100 60 Vitamin E IU 0.7 3 Vitamin K mcg 48 Thiamine (Vitamin B1) mcg 40 100 Riboflavin (Vitamin B2) mcg 60 150Vitamin B6 mcg 35 60 Vitamin B12 mcg 0.15 0.3 Niacin mcg 250 1050 Folicacid (Folacin) mcg 4 16 Pantothenic acid mcg 300 500 Biotin mcg 1.5 4.4Vitamin C (Ascorbic Acid) mg 8 12 Choline mg 7 16 Inositol mg 4 6Minerals: Calcium mg 60 78 Phosphorus mg 30 53 Magnesium mg 6 8 Iron mg0.15 3 1.8 Zinc mg 0.5 1 Manganese mcg 5 15 Copper mcg 60 90 Iodine mcg5 75 10 Sodium mg 20 60 27 Potassium mg 80 200 108 Chloride mg 55 150 65

TABLE 4 Development of the Base of Ready-To-Feed (RTF) Ultra-Pasteurized(UP) or Pasteurized (P) Infant Formula from Cow's Skim Milk CompositionDescription Protein Lactose Desirable RTF Infant Formula 14.2 (g/l)73.68 (g/l) Cow Milk¹ 34 (g/l) 48 (g/l) Starting Ratio cow/infantformula 2.39 0.65 Add water to 1 liter of cow milk 1.39 Liters Half wayRatio of cow/RTF infant formula 1 0.27 Add lactose to the resultant 2.39liters of (cow 128.1 g milk + water) Final Ratio of cow/RTF infantformula 1 1 Add appropriate quantity of desirable fats, vitamins &minerals, and other necessary or desirable ingredients Process (UP or Pincluding Homogenization), package and store at refrigeratedtemperatures ¹Alan Varnam & Jane Sutherland Milk and Milk Products,Technology, Chemistry and Microbiology Chapman & Hall, New York, NY 1994

TABLE 5 Development of the Base of Concentrated Ultra-Pasteurized (UP)or Pasteurized (P) Infant Formula from Cow's Skim Milk CompositionDescription Protein Lactose Desirable² Concentrated Infant Formula 28.4(g/l) 147.36 (g/l) Cow Milk³ 34 (g/l) 48 (g/l) Starting Ratio cow/infantformula 1.197 0.326 Add water to 1 liter of cow milk 0.197 Liters Halfway Ratio of cow/Conc. infant formula 1 0.275 Add lactose to theresultant 1.197 liters of 128.4 g (cow milk + water) Final Ratio ofcow/Conc. infant formula 1 1 Add appropriate quantity (2 times of RTFformula) of desirable fats, vitamins & minerals, and other necessary ordesirable ingredients Process (UP or P including Homogenization),package and store at refrigerated temperatures. ²According to CFR:“Standard dilution is equal amounts of concentrated liquid and water”³Alan Varnam & Jane Sutherland Milk and Milk Products, Technology,Chemistry and Microbiology Chapman & Hall, New York, NY 1994

TABLE 6 Source and Quantity of Added Vitamins to be Used with the RTFUltra-Pasteurized or Pasteurized Infant Formula from Cow's Skim MilkLabel Source to Vitamin Processing & Claim, Conversion Storage VitaminPremix Units Units/liter Food-Grade Source/Compound Factor OverdoseVitamins: Vitamin A IU 2028 Vitamin A Palmitate 1.9 1.2 Vitamin D IU405.6 Vitamind D3 (cholecalciferol) 1 1.2 Vitamin E IU 20.28Alpha-tocopheryl acetate 1 1.2 Vitamin K mcg 54.08 Phylloquinone(phytonadione) 1 1.1 Thiamine (Vitamin B1) mcg 676 Thiamin monoitrate 11.2 Riboflavin (Vitamin B2) mcg 1014 Riboflavin 1 1.2 Vitamin B6 mcg405.6 Pyridoxine hydrochloride 1.21 1.2 Vitamin B12 mcg 2.03Cyanocobalamin 1 1.2 Niacin mcg 7098 Niacinamide 1 1.1 Folic acid(Folacin) mcg 108.16 Folic Acid 1 1.2 Pantothenic acid mcg 3380 CalciumPantothenate 1.09 1.2 Biotin mcg 29.74 Biotin 1 1.2 Vitamin C (AscorbicAcid) mg 81.12 Sodium Ascorbate 1.12 2 Choline mg 81.12 Cholinebitartarate 3.71 1.1 Inositol mg 81.12 m-inositol 1 1.1 Taurine mg 540Taurine 1 1.1 L-carnitine mg 32.8 L-carnitine 1 1.1

TABLE 7 Source and Quantity of Added Minerals to be Used with the RTFUltra-Pasteurized or Pasteurized Infant Formula from Cow's Skim MilkLabel Processing & Claim, Source to Mineral Storage Mineral Premix UnitsUnits/Liter Food-Grade Source/Compound Conversion Factor Overdose FactorMinerals: Calcium mg 527.28 Phosphorus mg 377 Magnesium mg 54.08Magnesium Chloride (MgCl₂.6H₂O) 8.47 Iron mg 12.17 Ferrous Sulfate(FeSO₄.7H₂O) 4.98 1 Zinc mg 6.67 Zinc Sulfate (ZnSO₄.1H₂O) 2.76 1Manganese mcg 101.4 Maganese Sulfate (MnSO₄.1H₂O) 3.07 1 Copper mcg608.4 Cupric Sulfate (CuSO₄), anhydrous 2.51 1 Iodine mcg 67.6 PotassiumIodide (KI), anhydrous 1.31 1 Sodium mg 230 Potassium mg 730.08 Chloridemg 439.4

TABLE 8 Ingredient/Premix Preparation of Ready-To-Feed (RTF) InfantFormula Example 1A Batch/ Ingredient/Premix Units 1 Liter Whey ProteinConcentrate G 0.88 Protein Premix G 0.88 Canola Oil G 32.25 Soy LecithinG 3.58 Fat Premix G 35.83 Lactose G 57.72 Carrageenan G 0.22Carbohydrate Premix G 57.74 Mineral Premix g 2 MgCl₂ g 0.051 MineralPremix and Balance g 2.051 Vitamin Premix g 1 cytidine 5′-monophosphateg 0.008 disodium uridine 5′monophosphate g 0.008 disodium guanosine5′monophosphate g 0.008 adenosine 5′monophosphate g 0.008 NucleotidePremix g 0.032 Water: Amount of water per liter of Infant Formula (i.e.,1.39 L water/2.39 L water + skim Milk) according to calculation based onprotein and lactose may be reduced to meet the label claim for amount ofwater. This is due to volume obtained by other ingredients in thesystem.

TABLE 9 Batching and Processing Procedure for the Preparation ofReady-To-Feed (RTF) Infant Formula Example 1A Batch/ Ingredient/PremixUnits 1 Liter Pre-Batching Condition Batching Process Condition CIP thetotal system Water ml 391.3 Warm (70° C.) Add to the batching tankNonfat Milk ml 397.1 Warm (70° C.) Mix to uniformity Protein Premix g0.88 Well-mixed Mix to uniformity Fat Premix g 35.83 Well-mixed, Warm(70° C.) Mix to uniformity Carbohydrate Premix g 57.74 Well-mixed Mix touniformity Mineral Premix & Balance g 2.051 Dissolve in 100 ml WARMwater Homogenize & Mix to uniformity Vitamin Premix g 1 Dissolve in 50ml COLD Water Mix to uniformity Nucleotide Premix g 0.032 Add to thevitamin premix Water, IF NEEDED to 1 Liter Room Temperature Mix & BlendPASTEURIZE: Heat (center of product to 85° C. for 30 seconds), coolimmediately

TABLE 10 Ingredient/Premix Preparation of Ready-To-Feed (RTF) InfantFormula with Dextrose Example 1B Batch/ Ingredient/Premix Units 1 LiterWhey Protein Concentrate g 0.88 Protein Premix g 0.88 Canola Oil g 32.25Soy Lecithin g 3.58 Fat Premix g 35.83 Lactose g 29.02 Dextrose g 28.5Carrageenan g 0.22 Carbohydrate Premix g 57.74 Mineral Premix g 2 MgCl₂g 0.051 Mineral Premix and Balance g 2.051 Vitamin Premix g 1 Cytidine5′monophosphate g 0.008 Disodium uridine 5′monophosphate g 0.008Disodium guanosine g 0.008 5′monophosphate Adenosine 5′monophosphate g0.008 Nucleotide Premix g 0.032 Water: Amount of water per liter ofInfant Formula (i.e., 1.39 L water/2.39 L water + skim Milk) accordingto calculation based on protein and lactose may be reduced to meet thelabel claim for amount of water. This is due to volume occupied by otheringredients in the system.

TABLE 11 Batching and Processing Procedure for the Preparation ofReady-To-Feed (RTF) Infant Formula with Dextrose Example 1B Batch/Ingredient/Premix Units 1 Liter Pre-Batching Condition Batching ProcessCondition CIP the total system Water ml 391.3 Warm (70° C.) Add to thebatching tank Nonfat Milk ml 397.1 Warm (70° C.) Mix to uniformityProtein Premix g 0.88 Well-mixed Mix to uniformity Fat Premix g 35.83Well-mixed, Warm (70° C.) Mix to uniformity Carbohydrate Premix g 57.74Well-mixed Mix to uniformity Mineral Premix & Balance g 2.051 Dissolvein 100 ml WARM water Homogenize & Mix to uniformity Vitamin Premix g 1Dissolve in 50 ml COLD Water Mix to uniformity Nucleotide Premix g 0.032Add to the vitamin premix Water, IF NEEDED to 1 Liter Room TemperatureMix & Blend PASTEURIZE: Heat (center of product to 85° C. for 30seconds), cool immediately

TABLE 12 Ingredient/Premix Preparation of Concentrated Infant FormulaExample 2A Batch/ Ingredient/Premix Units 1 Liter Whey ProteinConcentrate g 1.76 Protein Premix g 1.76 Canola Oil g 64.5 Soy Lecithing 7.16 Fat Premix g 71.66 Lactose g 115.04 Carrageenan g 0.22Carbohydrate Premix g 115.26 Mineral Premix g 4 MgCl₂ g 0.102 MineralPremix and Balance g 4.102 Vitamin Premix g 2 Cytidine 5′monophosphate g0.016 Disodium uridine 5′monophosphate g 0.016 Disodium guanosine g0.016 5′monophosphate Adenosine 5′monophosphate g 0.016 NucleotidePremix g 0.064 Water: Amount of water per liter of Infant Formula (i.e.,0.197 L water/1.197 L water + skim Milk) according to calculation basedon protein and lactose may be reduced to meet the label claim for amountof water. This is due to volume occupied by other ingredients in thesystem.

TABLE 13 Batching and Processing Procedure for the Preparation ofConcentrated Infant Formula Example 2A Batch/ Ingredient/Premix Units 1Liter Pre-Batching Condition Batching Process Condition CIP the totalsystem Nonfat Milk ml 794.2 Warm (70° C.) Add to the batching tankProtein Premix g 1.76 Well-mixed Mix to uniformity Fat Premix g 71.66Well-mixed, Warm (70° C.) Mix to uniformity Carbohydrate Premix g 115.26Well-mixed Mix to uniformity Mineral Premix & Balance g 4.102 Dissolvein 41.2 ml WARM water Homogenize & Mix to uniformity Vitamin Premix g 2Dissolve in 41.2 ml COLD Water Mix to uniformity Nucleotide Premix g0.064 Add to the vitamin premix Water, IF NEEDED to 1 Liter RoomTemperature Mix & Blend PASTEURIZE: Heat (center of product to 85° C.for 30 seconds), cool immediately

TABLE 14 Ingredient/Premix Preparation of Concentrated Infant Formulawith Dextrose Example 2B Batch/ Ingredient/Premix Units 1 Liter WheyProtein Concentrate g 1.76 Protein Premix g 1.76 Canola Oil g 64.5 SoyLecithin g 7.16 Fat Premix g 71.66 Lactose g 58.04 Dextrose g 57Carrageenan g 0.22 Carbohydrate Premix g 115.26 Mineral Premix g 4 MgCl₂g 0.102 Mineral Premix and Balance g 4.102 Vitamin Premix g 2 Cytidine5′monophosphate g 0.016 Disodium uridine 5′monophosphate g 0.016Disodium guanosine g 0.016 5′monophosphate Adenosine 5′monophosphate g0.016 Nucleotide Premix g 0.064 Water: Amount of water per liter ofInfant Formula (i.e., 0.197 L water/1.197 L water + skim Milk) accordingto calculation based on protein and lactose may be reduced to meet thelabel claim for amount of water. This is due to volume occupied by otheringredients in the system.

TABLE 15 Batching and Processing Procedure for the Preparation ofConcentrated Infant Formula with Dextrose Example 2B Batch/Ingredient/Premix Units 1 Liter Pre-Batching Condition Batching ProcessCondition CIP the total system Nonfat Milk ml 794.2 Warm (70° C.) Mix touniformity Protein Premix g 1.76 Well-mixed Mix to uniformity Fat Premixg 71.66 Well-mixed, Warm (70° C.) Mix to uniformity Carbohydrate Premixg 115.26 Well-mixed Mix to uniformity Mineral Premix & Balance g 4.102Dissolve in 41.2 ml WARM water Homogenize & Mix to uniformity VitaminPremix g 2 Dissolve in 41.2 ml COLD Water Mix to uniformity NucleotidePremix g 0.064 Add to the vitamin premix Water, IF NEEDED to 1 LiterRoom Temperature Mix & Blend PASTEURIZE: Heat (center of product to 85°C. for 30 seconds), cool immediately

What is claimed is:
 1. A refrigeration-shelf-stable infant formula beingthermally treated under conditions of ultra-pasteurization orpasteurization having a nutritional composition comprising per 100kilocalories: a. from about 4.4 to about 6.4 grams of total fat; b.linoleic acid from about 8 to about 35 percent of total fat on weightbasis; c. α-linolenic acid from about 1.75 to about 4 percent of totalfat on weight basis; d. from about 1.7 to about 3.4 grams of protein; e.from about 1.2 to about 2 mg of Carnitine; f. from about 0 to about 12mg of Taurine; g. from about 0 to about 16 mg of Nucleotides; h. fromabout 7 to about 30 mg of Choline; i. from about 4 to about 40 mg ofInositol; j. from about 9 to about 13 grams of carbohydrate; k. fromabout 50 to 140 mg of Calcium; l. from about 20 to about 70 mg ofPhosphorus; m. from about 4 to about 17 mg of Magnesium; n. from about0.2 to about 1.65 mg of Iron; o. from about 0.4 to about 1 mg of Zinc;p. from about 1 to about 100 mcg of Manganese; q. from about 60 to about160 mcg of Copper; r. from about 8 to about 35 mcg of Iodine; s. fromabout 25 to about 50 mg of Sodium; t. from about 60 to about 160 mg ofPotassium; u. from about 50 to about 160 mg of Chloride; v. from about1.5 to about 5 mcg of Selenium; w. from about 0 to about 60 mcg ofFluoride; x. from about 200 to about 500 IU of Vitamin A; y. from about40 to about 100 IU of Vitamin D; z. from about 0.5 to about 5.0 mg ofVitamin E per gram of polyunsaturated fatty acids, wherein saidpolyunsaturated fatty acids are from about 0.4 to about 2.5 grams; aa.from about 1 to about 25 mcg of Vitamin K; bb. from about 30 to about200 mcg of Thiamine or Vitamin B I; cc. from about 80 to about 300 mcgof Riboflavin or Vitamin B2; dd. from about 550 to about 2000 mcg ofNiacin; ee. from about 30 to about 130 mcg of Vitamin B6; ff. from about0.08 to about 0.7 mcg of Vitamin B12; gg. from about 11 to about 40 mcgof Folic Acid or Folacin; hh. from about 300 to about 1200 mcg ofPantothenic Acid: ii. from about 1 to about 15 mcg of Biotin; and jj.from about 6 to about 15 mcg of Vitamin C or Ascorbic Acid; wherein thetotal caloric content is from about 80 kilocalories to about 300kilocalories per 150 milliliters or 5 fluid ounces.
 2. The infantformula of claim 1 wherein, said infant formula is ready-to-feed infantformula or a concentrated infant formula.
 3. The infant formula of claim1 wherein, said infant formula is an exempt infant formula.
 4. Theinfant formula of claim 1 wherein, said infant formula further includesskim milk, lactose-free skim milk, low fat milk, whole milk, organicmilk and combinations thereof.
 5. The infant formula of claim 1 wherein,said infant formula further includes milk selected from a group ofanimals consisting of cow, sheep, goat, buffalo, camel, llama, mare,deer and combinations thereof.
 6. The infant formula of claim 1 having arefrigeration shelf-life of up to 16 weeks at temperatures of from about1° C. to about 7° C.
 7. The infant formula of claim 1, wherein saidinfant formula is in a package assembly comprising a gable-top carton ora plastic container.
 8. The infant formula of claim 1 wherein saidultra-pasteurization is conducted at 130° to about 150° C. for about 2to about 5 seconds or said pasteurization is conducted at about 75° toabout 95° C. for about 15 to about 55 seconds.
 9. The infant formula ofclaim 1 further including additional amounts of natural antioxidantsselected from the group consisting of vitamin C, vitamin E,beta-carotene, selenium, zinc, and combinations thereof.
 10. The infantformula of claim 1, wherein the source of protein is selected from thegroup consisting of skim milk, lactose-free skim milk, casein orcaseinate, whey protein, whey protein concentrate, whey protein isolate,milk protein concentrate, milk protein isolate, soy protein, andcombinations thereof.
 11. The infant formula of claim 1, wherein thesource of fat is selected from the group consisting of vegetable oils,medium chain triglycerides, short chain triglycerides and combinationsthereof.
 12. The infant formula of claim 1, wherein the source ofcarbohydrate is selected from the group consisting of lactose, sucrose,corn syrup solids, dextrose, glucose, fructose, honey, rock candy,maltodextrin or combination thereof.
 13. The infant formula of claim 1,wherein said infant formula is a hypoallergenic infant formula havingprotein selected from enzymatically-hydrolyzed proteins or peptides,amino acids, and combinations thereof.
 14. The infant formula of claim1, wherein said infant formula is without iron fortification.
 15. Theinfant formula of claim 1, wherein said infant formula is lactose-freeor lactose-reduced.
 16. The infant formula of claim 1, wherein theinfant formula is a soy-based infant formula having soy protein as theprotein source.